Boston S
cientific (Master Brand DFU
Template 8.2677in x 1
1.6929in
A4, 9223851
9A) eDFU
, MB, EXAL
T Controller
, EN, 508661
31
-0
1 R
ev
. A
Black (K) ∆E ≤5.0
Immunity Test
IEC 60601
Test Level
Compliance Level
Electromagnetic Environment
(Guidance)
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to
80 MHz
3 Vrms
Portable and mobile RF communications
equipment should be used no
closer to any part of the EXALT
Controller, including cables, than the
recommended separation distance
calculated from the equation applicable
to the frequency of the transmitter.
Recommended separation distance
d=1.2√P
d=1.2√P
80 MHz to 800 MHz
d=2.3√P
800 MHz to 2.5 GHz
Where P is the maximum output
power rating of the transmitter in
watts (W) according to the transmitter
manufacturer and d is the recommended
separation distance in meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site surveya, should be
less than the compliance level in each
frequency rangeb.
Interference may occur in the vicinity
of equipment marked with the following
Symbol:
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to
2.5 GHz
3 V/m
Note 1 —At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2 —These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due
to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the EXALT Controller is used exceeds the applicable RF
compliance level above, the EXALT Controller should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the EXALT Controller.
b) Over the frequency range 150 kHz to 80 MHz, the field strengths should be less than 3 V/m.
Appendix 3—Guidance and Manufacturer’s Declaration— electromagnetic IMMUNITY – for ME
Equipment and ME Systems that are not LIFE-SUPPORTING
The EXALT™ Controller is intended for use in the electromagnetic environment specified below (Table 8).
The customer or the user of the EXALT Controller should assure that it is used in such an environment.
Table 8. Guidance and manufacturer’s declaration—electromagnetic immunity IEC 60601-1-2
(4th edition)
Immunity Test
IEC 60601
Test Level/ Compliance Level
Electromagnetic Environment
(Guidance)
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 8 kV contact
± 15 k/V air
Floors should be wood, concrete, or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Electrical fast
transient / burst
IEC 61000-4-4
± 2 kV for power supply lines
± 1 kV for input/output lines
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
± 1 kV differential mode
± 2 kV common mode
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage dips
IEC 61000-4-11
0% UT; 0.5 cycle
At 0°, 45°, 90°, 135°, 180°,
225°, 270°, and 315°
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the EXALT
Controller requires continued operation
during power mains interruptions, it is
recommended that the EXALT Controller
be powered from an uninterruptible
power supply or a battery.
0% UT; 1 cycle
and
70% UT; 25/30 cycles
Single phase: at 0°
Voltage
interruptions
IEC 61000-4-11
0% UT; 250/300 cycle
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the EXALT
Controller requires continued operation
during power mains interruptions, it is
recommended that the EXALT Controller
be powered from an uninterruptible
power supply or a battery.
Power frequency
(50/60 Hz)
magnetic field IEC
61000-4-8
30 A/m
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
Note—UT is the a.c. mains voltage prior to application of the test level.
